Henry Schein

FDA UDI

Class I (US FDA UDI)

by Henry Schein, Inc.

Identity

Trade Name: Henry Schein FDA UDI
Generic Name: Multiple urine analyte IVD, kit, rapid colorimetric, clinical FDA UDI
Device Name: Urispec + UA Reader w 4 Promo FDA UDI
Model / Reference: 5700317 FDA UDI
Description: Urispec + UA Reader w 4 Promo FDA UDI

Identifiers

Catalog Number: 5700317 FDA UDI
Primary DI / UDI-DI: 00304040006580 FDA UDI
FDA Product Code: KSL FDA UDI
JIP FDA UDI
CEN FDA UDI
JMT FDA UDI
JIN FDA UDI
KQO FDA UDI
JJB FDA UDI
JMA FDA UDI
CDM FDA UDI
JIR FDA UDI
JIL FDA UDI
LJX FDA UDI
GMDN Term: Multiple urine analyte IVD, kit, rapid colorimetric, clinical FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 864.9320 FDA UDI
864.6550 FDA UDI
862.1550 FDA UDI
862.1510 FDA UDI
862.1435 FDA UDI
862.2900 FDA UDI
862.1115 FDA UDI
862.1095 FDA UDI
862.1785 FDA UDI
862.1645 FDA UDI
862.1340 FDA UDI
864.7675 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Multiple urine analyte IVD, kit, rapid colorimetric, clinical Urine analyser IVD, laboratory, semi-automated

Henry Schein by Henry Schein, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Urine analyser IVD, laboratory, semi-automated.

CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
AUTION™ MAX AX-4022 Analyzer — ARKRAY USA, INC. · Class I
AUTION™ Sticks 10EA Test Strips — ARKRAY USA, INC. · Class I
Henry Schein — HENRY SCHEIN, INC. · Class I
Henry Schein — HENRY SCHEIN, INC. · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Henry Schein, Inc.

Sources (1)

FDA UDI 076f35fd-3cba-4fb0-b0f8-4d3dbe4de132 35 fields · synced May 30, 2026